cobas¿ Liat¿ Analyzer
Reported: July 27, 2016 Initiated: May 9, 2016 #Z-2216-2016
Product Description
cobas¿ Liat¿ Analyzer
Reason for Recall
Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 2
- Distribution
- Distributed in NC and WA.
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
cobas¿ Liat¿ Analyzer. Recalled by Roche Molecular Systems, Inc.. Units affected: 2.
Why was this product recalled? ▼
Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2016. Severity: Moderate. Recall number: Z-2216-2016.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11